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December 22, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU

Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024Company reaffirms potential for European approval for ONS-5010 with Marketing Authorization Application...
December 19, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Submits Special Protocol Assessment (SPA) to FDA for Non-Inferiority Study of ONS-5010

NORSE EIGHT study on track to commence in Q1 2024Resubmission of ONS-5010 Biologics License Application (BLA) in the U.S. expected by the end of calendar year 2024 ISELIN, N.J., Dec. 19, 2023 ...
December 06, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Announces Strategic Organizational Realignment

Realignment focused on supporting ONS-5010 U.S. and EU regulatory and commercial prioritiesContinued progress toward commencement of additional adequate and well-controlled study to support the...
November 27, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Announces Receipt of Type A Meeting Minutes and Reiterates Regulatory Path Forward for ONS-5010

Resubmission of the ONS-5010 BLA on track for the end of calendar year 2024, pending final agreement on a clinical trial protocol with the FDA and successful completion of the required additional...
November 14, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Adds Global Commercial Expertise with Appointment of Jedd Comiskey as Senior VP - Head of Europe

ISELIN, N.J., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of...
November 02, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Provides Update on Type A Meetings with FDA

ISELIN, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of...
November 01, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® to Present at Guggenheim’s 5th Annual Inflammation, Neurology & Immunology (INI) Conference

ISELIN, N.J., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of...
September 29, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Requests Type A Meeting With FDA

ISELIN, N.J., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of...
September 21, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® to Present at the 2023 Cantor Fitzgerald Global Healthcare Conference

ISELIN, N.J., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of...
September 05, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® to Present at the H.C. Wainwright 25th Annual Global Investment Conference

ISELIN, N.J., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of...